Dr. Farsalinos Submits Official Complaint To FDA Over Anti-Vaping Study That “Provides No Reliable Scientific Information”

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The renowned tobacco control expert has once again taken the lead in the fight against false vaping information, casting major aspersions on research presented at the annual American Heart Association Scientific Sessions

Once again it’s Dr. Konstantinos Farsalinos that is fighting the good fight against false vaping information. This time he is calling into question research that was recently presented as part of the 2017 American Heart Association Scientific Sessions. The study in question was just published last week and was conducted by researchers at the University of California, San Francisco. Their report claimed to prove that the vapor produced by Heat not Burn (HnB) technology was as impactful to Flow-Mediated Dilation (FMD), as traditional tobacco smoke.

Dr. Farsalinos saw several flaws with this report and was quick to submit an official comment to the FDA about its validity. He has become one of the premier voices in vaping advocacy primarily by conducting replication studies that attempt to recreate the results of negative vaping studies. Just earlier this month he released two of these replication studies, both being unable to repeat the damning results without testing conditions that “no vaper will ever be exposed [to].” So it’s only right that he’s now appealing to the FDA about this brand new misleading study.

Dr. Farsalinos Official Comment

There are three main objections that Dr. Farsalinos has with the American Heart Association backed study. First and foremost he questions the purpose of studying nicotine-containing cigarettes and e-cigarettes for their effect on the Flow-Mediated Dilation. Specifically, why would the researchers claim that FMD function is an important prognostic indicator, and base their whole report on it?

Dr. Farsalinos uses the guidelines published by the International Brachial Artery Reactivity Task Force to back up his stance. They clearly indicate that many factors can have a significant impact on measuring FMD, such as temperature, food, and outside stimulus, such as nicotine use. This is a well-known effect of nicotine on the body, and this includes medically sanctioned nicotine replacement therapies, such as patches and gum. Not only that, but according to Dr. Farsalinos, “no study has ever found FMD to be a prognostic marker of disease when the measurement was made after an acute exposure to a stimulant.” Because of this, in the doctor’s opinion, measuring the FMD response to an acute stimulus is unlikely to provide any useful information at all.

The second major problem with the UC San Francisco study is that it shouldn’t be possible for the same amount of Heat not Burn vapor and traditional cigarette smoke to result in similar nicotine serum levels. But this is precisely what the researchers supposedly found. This in spite of the several independent studies that have all shown Heat not Burn vapor delivers around 30% less nicotine than traditional cigarettes. This paradoxical finding makes Dr. Farsalinos question the research methods entirely, stopping just short of flat-out accusing them of tampering with their conclusions.

Undoubtedly bolstering his concerns over ethics, is the curious omission of information that he believes would typically have resulted in a completely different conclusion for researchers. The only way he sees that this could happen is if it was being actively suppressed. This is his third major issue with the testing, and it focuses on the circumstances in which HnB vapor was able to register such high nicotine serum levels. This information was explicitly noted in the report and even the subsequent media statements, but for some reason, this critical piece of information was left out of the abstract.

According to Dr. Farsalinos, the only way to register a 4.5 fold increase in nicotine serum using HnB technology is to expose the subjects much more thoroughly. If this is indeed how the researchers got such high nicotine serum levels in the first place, their conclusion should undoubtedly have been centered around it taking 4.5 times more exposure to result in the same effect on FMD as traditional tobacco smoke. The fact that they apparently wanted this to be overlooked gives Dr. Farsalinos all of the more reason to believe that it wasn’t just a mistake in test design, but rather a concerted effort to make vaping appear more dangerous than it actually is.

Implications

Overall the problem with studies like this is not the studies themselves, but rather how the media decides to sell them. The truth is that in the Internet age, there will always be conflicting pieces of research that can be found to support your beliefs. So the real issue is that the mainstream media decided to pick a side and only report research that agrees. This is what leads to a lot of arguments in society at large, and vaping is no exception to be sure.

Dr. Farsalinos agrees, he has often warned against the bombastic media picking and choosing what to report. The simple truth is that it’s easier to sell negative information than positive stuff. As a result, reports that use a scary headline are the ones that gain traction and potentially become prevalent beliefs. That’s why it’s so important that we support and spread the work done by advocates like Dr. Farsalinos if we want to fight the false narratives pushed by the fear-mongering media.

Do you agree with Dr. Farsalinos’ objections? Do you think that the UC San Francisco researchers purposefully altered their results? Is it important to support work like this, or does it not make a big difference? Let us know what you think in the comments.

Dustin has been vaping for almost a decade. He found e-cigarettes in 2008 and quickly became drawn to them as an early adopter. He's been writing reviews ever since and has established himself as a well-versed authority on the subject.

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3 Responses

  1. Vista Vapors Inc says:

    Thank you to Dr. Farsalinos for bringing new studies to the FDA’s attention and for pushing back against the misinformation about vaping!

  2. Mike says:

    Of Course it matters! Those self appointed guardians of public health (incl AHA) who raise their funds tax free by preying on peoples fears are actively skewing the science in a way that harms public health. Why doesn’t some reporter write THAT story?

  3. TobaccoFree says:

    They did Mike, it’s reported in a documentary titled “A Billion Lives”. Keep up the great work Dr. Farsalinos!

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